Gliclazide sustained-release tablet dissolution curve determination method, similarity evaluation method and application thereof

Abstract

The invention discloses a gliclazide sustained-release tablet dissolution curve determination method, a similarity evaluation method and application thereof. A flow cell closed-loop or open-loop system is adopted to determine the dissolution rates of gliclazide sustained release tablets at different time points under different conditions, the dissolution curves are drawn, and then the similarity of the dissolution curves is evaluated through a similarity factor f2. Experiment conditions can be flexibly changed, dynamic simulation of the human gastrointestinal tract physiological environment can be achieved, an open-loop system can provide continuous fresh dissolution media, proper leakage groove conditions can be provided for indissolvable drugs, the quality of gliclazide sustained-release tablets can be better reflected, the defects of a traditional dissolution determination method are overcome, and the dissolution determination result is closer to the in-vivo release behavior of the drug, so that the method has more practical significance, is wide in applicable dosage form, and can provide data support for the consistency evaluation work of the imitated preparation and the reference preparation.

Description

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AI Technical Summary

Benefits of technology

This patented technology describes an apparatus that uses special liquids (liquid droplets), called gels). These liquid droplexes are placed on top of another solid material like paper. When these two materials come into contact with each other they create tiny holes within them through which small particles from one substance enter. By measuring how fast it takes certain chemical reactions happening inside those tiny spaces, researchers have been able to determine various physical properties related to absorption and release rates of specific compounds. They also found out if there were any differences when comparing different forms of medicine made up of similar molecules. Overall, this new technique allows scientists to study complex systems involving many types of medicines more easily compared without having to perform complicated experiments themselves.

Problems solved by technology

This patents describes various methods for studying how well medicine works when taken through its natural environment (oral cavity). These techniques include tests like dissolving plasters into water, measuring their properties before use, and analyzing them afterwards. Different ways were explored during these experiments to determine if they could be effective at treating diseases related to poor gut function caused by excessive intake of sugars. Additionally, there was a problem where patients treated with conventional medicines had reduced levels of beta blockers due to side effects associated with prolonged periods after taking them. To address this issue, some manufacturors developed slow releasing tables containing gliczides instead of sucrose.

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